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| Name | Class |
|---|---|
| University of California, Riverside | OTHER |
| Premier Research | OTHER |
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This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl ~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.
Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study.
At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecopipam HCl ~2mg/kg/day | Experimental | Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks |
|
| Matching Placebo | Placebo Comparator | Matching placebo tablets for daily, oral administration for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecopipam | Drug | Oral tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12 | Measures stuttering severity in children and adults | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Severity (CGI-S) baseline to Week 12 | Rates the severity of the subject's illness at the time of assessment, relative to the the clinician's past experience with patients who have the same diagnosis. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul R Mahableshwarkar, MD, DFAPA | Emalex Biosciences Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Riverside | Riverside | California | 92501 | United States | ||
| CI Trials |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 20, 2023 | Apr 13, 2023 | 9 | ||
| Apr 18, 2024 |
| ID | Term |
|---|---|
| D000067454 | Childhood-Onset Fluency Disorder |
| D013342 | Stuttering |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
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| ID | Term |
|---|---|
| C058081 | ecopipam |
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| Drug |
Oral tablet |
|
| Santa Ana |
| California |
| 92705 |
| United States |
| Clinical Neuroscience Solutions Inc | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions Inc | Orlando | Florida | 32801 | United States |
| Institute For Advanced Medical Research | Atlanta | Georgia | 30341 | United States |
| Social Psychiatry Research Institute | Prairie Village | Kansas | 66208 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Social Psychiatry Research Institute | Brooklyn | New York | 11235 | United States |
| Clinical Neuroscience Solutions Inc | Memphis | Tennessee | 38119 | United States |
| May 13, 2024 |
| 10 |
| Aug 7, 2025 | Aug 22, 2025 | 11 |
| May 20, 2026 | Jun 15, 2026 | 12 |
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |